Job Title: Quality System Specialist (Deviations and CAPAs)
We are collaborating with a global pharmaceutical company to fill a vacancy for a Quality System Specialist. The primary purpose of this position is the management of the Quality System functions in the organisation in relation to Deviations and CAPAs.
Key Responsibilities:
* Support the organisation in the management of a Deviation system
* Facilitate cross-functional meetings and provide guidance and consultation to deviation stakeholders
* Collaborate with other departments on completion of investigations and root cause analysis
* Support the establishment and implementation of effective corrective/preventative actions
* Support the organisation in the management of a CAPA system
* Manage CAPAs that derive from various processes, including deviations and internal audits
* Facilitate cross-functional meetings and provide guidance and consultation to CAPA owners
* Collaborate with other departments on completion of CAPAs
Requirements:
* Pharmacist or Engineer with a master's degree in quality, Regulatory or scientific topic
* A minimum of 2+ years of experience in pharmaceutical or biotechnology industries
* Relevant experience in either quality, regulatory, manufacturing, or development
* Understanding of GxPs, quality systems and regulations (EU, FDA, ICH)
* Proficient digital literacy in Microsoft (MS) Word, Excel, Power Point, and Share Point required
* Experience with Quality Management Systems heavily preferred
Skills:
* Quality systems
* QMS
* Deviation
* CAPA
The ideal candidate will have excellent interpersonal, written, and oral communication skills, with the ability to utilise active listening skills to understand concerns or reasoning to be responsive, gain trust and build strategic relationships. They will also be able to work in an international matrix environment and be fluent in English, with French or other languages being a plus.